MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT

Model Number EK2420FNT2

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

Patient Problems Laceration(s) (1946); Perforation (2001)

Event Date 02/06/2022

Event Type  Injury  

Event Description

The doctor very experienced in the use of this type of stent, recently reports a difficulty on the introduction of the delivery due to the kinking of the part in correspondence with the proximal yellow marker which limits its sliding on the guide wire and which in this case has caused a severe laceration in the mucosa of the esophagus with severe perforation after 15 days.

Manufacturer Narrative

It was reported that there was difficulty on the introduction of the delivery due to the kinking of the delivery system, limiting sliding on the guide wire and caused a severe laceration in the mucosa of the esophagus with severe perforation after 15 days.Based on the attached photo, it is confirmed that kinking occurred on the outer sheath.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.Perforation can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is difficult to identify the exact root cause because it is difficult to reconstruct the situation at the time of procedure.However, based on the description "difficulty on the introduction of the delivery due to the kinking of the delivery system, limiting sliding on the guide wire and caused a severe laceration in the mucosa of the esophagus with severe perforation after 15 days" and kinking that occurred on the outer sheath in the attached photo, it is assumed that kinking occurred during insertion of the delivery system due to the strong pressure of the stenosis, condition of the patient's lesion and other factors, causing difficulty in insertion through the guide wire.Then, it is assumed that severe laceration in the mucosa of the esophagus occurred during additional attempt for insertion of the delivery system, and perforation occurred 15 days later.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: perforation".This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 15037214
• MDR Text Key: 296044891
• Report Number: 3003902943-2022-00016
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EK2420FNT2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR